# FDA recall D-1168-2018

> **Akorn, Inc.** · Class III · drug recall initiated 2018-08-08.

## Product

Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10

## Reason for recall

Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-1168-2018
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-08
- **Report date:** 2018-09-05
- **Termination date:** 2020-11-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1168-2018

## Citation

> AI Analytics. FDA recall D-1168-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-1168-2018. Source: US FDA. Licensed CC0.

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